TPLC - Total Product Life Cycle

• Device: needle, fistula
• Regulation Description: Blood access device and accessories.
• Product Code: FIE
• Regulation Number: 876.5540
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
CORDIS CORP.
	SUBSTANTIALLY EQUIVALENT	1
EXELINT INTERNATIONAL CO
	SUBSTANTIALLY EQUIVALENT	1
EXELINT INTERNATIONAL CO.
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS
	SUBSTANTIALLY EQUIVALENT	1
GAMBRO
	SUBSTANTIALLY EQUIVALENT	1
JMS
	SUBSTANTIALLY EQUIVALENT	12
KENDALL
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL COMPONENTS
	SUBSTANTIALLY EQUIVALENT	1
MEDISYSTEM
	SUBSTANTIALLY EQUIVALENT	6
NIPRO CORP
	SUBSTANTIALLY EQUIVALENT	6
NISSHO CORP
	SUBSTANTIALLY EQUIVALENT	1
TERUMO CARDIOVASCULAR SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
TOGO MEDIKIT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Dislodged	27
Crack	4
Disconnection	4
Hole in material	3
Retraction problem	3
Use of Device Issue	3
Safety interlock(s) inadequate	2
Leak	2
Needle, unsheathed	2
Unknown (for use when the device problem is not known)	2
Cut in material	2
Dislodged or dislocated	1
Malfunction	1
Difficult to remove	1
Unintended arm motion	1
Detachment of device component	1
Fitting problem	1
Other (for use when an appropriate device code cannot be identified)	1
Improper or incorrect procedure or method	1
Material separation	1
Fluid leak	1
Total Device Problems	64

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	0	0	0	0	1	1
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Medisystems Corp	II	Feb-29-2012
2	Medisystems a NX Stage Company	II	Jan-24-2013